Glucose monitoring devices (FDA cleared/home use) Medical Devices – Page 9

Below is a list of medical devices and their corresponding complexity (CLIA WAIVED, MODERATE, or HIGH) when testing for Glucose monitoring devices (FDA cleared/home use). Note that there may be additional pages of medical devices which test for Glucose monitoring devices (FDA cleared/home use) to choose from located at the bottom of the list.

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Medical Device – Page 9	COMPLEXITY
Bayer Contour Next Link Wireless Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Bayer Contour Next USB Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Bayer Contour USB Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Bayer DEXTROSTIX Reagent Strips Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Bayer Diagnostics Ascencia BREEZE 2 Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
BAYER DIAGNOSTICS ASCENCIA BREEZE BLOOD GLUCOSE METER Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
BAYER DIAGNOSTICS ASCENCIA ELITE BLOOD GLUCOSE METER Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
BAYER DIAGNOSTICS ASCENCIA ELITE XL BLOOD GLUCOSE METER Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
BAYER DIAGNOSTICS ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Bayer Diagnostics Ascensia DEX 2 Diabetes Care System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
BAYER DIAGNOSTICS ASCENSIA ELITE BLOOD GLUCOSE TEST STRIPS Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
BAYER DIAGNOSTICS ASCENSIA ELITE DIABETES CARE SYSTEM Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
BAYER DIAGNOSTICS GLUCODISC BLOOD GLUCOSE TEST STRIPS Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Bayer Didget Blood Glucose Monitoring System Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Bayer GLUCOFILM Test Strips Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Bayer GLUCOMETER 3 Blood Glucose Meter Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Bayer GLUCOMETER Blood Glucose Meter Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
Bayer GLUCOMETER DEX Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
BAYER GLUCOMETER DEX 2 Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED
BAYER GLUCOMETER DEX DIABETES CARE SYSTEM Analyte: Glucose monitoring devices (FDA cleared/home use)	CLIA WAIVED

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